Associate Director, Analytical Development

11 - 15 years experience  • 

Salary depends on experience
Posted on 03/20/18
Lexington, MA
11 - 15 years experience
Salary depends on experience
Posted on 03/20/18

The Associate Director is responsible for supporting global product development within the small molecule (SM) Process Development and Technical Sciences (PDTS) department.  This position is for a high level, experienced analytical professional to serve as an analytical subject matter expert and point of contact for Shire’s product development group (for synthetic APIs in a 100% outsourced model).  The candidate must have deep and broad expertise in analytical chemistry in support of active pharmaceutical ingredient (API) and drug product development.  The candidate will leverage their direct analytical experience to ensure the appropriate analytical methodologies are in place and fit-for-purpose to properly support the development projects.

This is an individual contributor role in which the candidate represents the PA group on multiple cross-functional project teams where they provide analytical expertise, associated regulatory support, and manage the analytical aspects of the projects.  This requires significant internal collaboration as well as the management of analytical activities conducted at external Contract Research Organizations (CROs).

As needed, the Associate Director will represent for Small Molecule Analytical Development, PDTS during meetings involving various Shire functions such as Regulatory Affairs, Quality Assurance, Technical Operations, and R&D management.

Responsibilities

 

60% Analytical Subject Matter Expert

  • In support of product development, apply broad and deep analytical knowledge and experience to the material characterization and testing of APIs and drug products.
  • Apply knowledge and direct experience to ensure the appropriate analytical methodologies are in place and fit-for-purpose to properly support the development projects.
  • Provide technical guidance for troubleshooting / investigating complex issues regarding analytical, stability, and process / product development.
  • Leverage fundamental understanding of formulations, product development, and material characterization to implement analytical methodologies as appropriate for various formulations and dosage forms.
  • Apply statistical analysis for interpretation of analytical and stability data.
  • Author and/or review analytical methods and associated development, qualification, validation and transfer protocols and reports.
  • Author and/or review release, in-process and stability specifications for APIs and drug products.
  • Manage and oversee stability and analytical studies for projects.  This includes authoring / reviewing protocols and reports as well as evaluating the results and leading technical discussions with project team members and external contractors.
  • Ensure all cGMP data generated for development projects are managed and evaluated as described in relevant internal procedures and regulatory requirements.
  • Quickly and effectively resolve complex analytical issues and deviations / investigations.
  • Effectively communicate complex technical issues and deliver concise presentations to management and non-technical stakeholders.
  • Actively contribute to the preparation and coordination of internal audits and regulatory inspections.
  • Provide technical input for selecting external Shire contractors and manage day-to-day contractor activities for respective projects.
  • Create and enhance collaborative and trusting relationships internally and with personnel at Contract Research Organizations (CROs).
  • Serve as a peer-leader to motivate / inspire colleagues and to mentor others in various aspects of analytical and problem-solving methodologies.
  • Maintain a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training courses.

20% Regulatory Submissions

  • Author and/or review relevant API and drug product CMC sections for global regulatory submissions (IND/CTA and NDA/MAA and annual reports) and ensure sections meet submission ready standards regarding content and format.
  • Assist with responses to regulatory agencies regarding stability and analytical-related inquiries.
  • Maintain awareness of current trends regarding global regulatory CMC requirements through literature and conference attendance.

20% Documentation / Compliance

  • Ensure analytical test methods, development reports, and specifications are compliant with internal procedures and regulatory requirements.
  • Assist in the development and implementation of departmental processes, procedures and policies.
  • Maintain adherence to departmental and quality systems, such as SOP training records, deviations/investigations, CAPAs, and Change Controls.
  • Actively contribute to the preparation and coordination of internal audits and regulatory inspections.
  • Supervise / coach less experienced staff as needed.

Education and Experience Requirements

  • Requires an advanced degree (MS or PhD) in Chemistry, Chemical Engineering, Pharmacy or closely related field and at least 10 years of relevant analytical experience within the Pharmaceutical Industry.
  • The following items are essential:
    • Direct experience with the analytical support of synthetic APIs and drug products
    • Strong knowledge of ICH and other regulatory guidelines
    • Knowledge and experience with product development and clinical supplies processes
    • Experience in authoring analytical-related CMC sections of IND/IMPD and NDA/MAA regulatory submissions
    • Experienceworking with Contract Research Laboratories
    • Proven experience with various quality systems (e.g. investigations / deviations, CAPAs, change controls, etc.)
  • The following items arepreferred:
    • Knowledge and experience with statistical applications for data evaluation
    • Knowledgeable in European and US CMC regulatory requirements for APIs and drug products
    • Familiarity with MHRA / FDA inspections and compliance experience

Req ID: R0020666

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